A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
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|ClinicalTrials.gov Identifier: NCT03809650|
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Thromboembolic Pulmonary Hypertension (CTEPH)||Drug: macitentan 10 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter, Open-label, Single Arm, Phase III Study to Assess the Efficacy and Safety of Macitentan (ACT-064992) in Subjects With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)|
|Actual Study Start Date :||January 8, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Open-label treatment period
oral administration of macitentan 10 mg once daily
Drug: macitentan 10 mg
macitentan 10 mg, film-coated tablet, oral use
Other Name: ACT-064992, Opsumit®
- Evaluate the ratio in pulmonary vascular resistance (PVR) at rest from baseline to Week 16 [ Time Frame: From Baseline to Week 16 ]The resistance in the artery carrying blood to the lungs is called PVR. The PVR is the resistance in the artery carrying blood to the lungs and that has to be overcome by the right ventricle in heart in order to let blood flow to the lungs occur. The ratio in PVR at rest indicates the efficacy of macitentan in patients with CTEPH. The ratio in PVR at rest is calculated as PVR at Week 16 divided by baseline PVR. The ratio in PVR at rest from baseline to Week 16 of administration of macitentan is evaluated in subjects with CTEPH who are not indicated for pulmonary endarterectomy (PEA) and/or subjects who have postoperative persistent or recurrent pulmonary hypertension (PH) after PEA and/or balloon pulmonary angioplasty (BPA).
- Change from baseline to Week 16 in PVR at rest [ Time Frame: From baseline to Week 16 ]The PVR at rest will be calculated to evaluate the change in PVR at rest from pre-dosing (baseline) to post-dosing (Week 16).
- Change from baseline to Week 16 in pulmonary vascular resistance index (PVRI) at rest [ Time Frame: From baseline to Week 16 ]The indexed PVR (PVRI) at rest will be calculated to evaluate the change in PVRI at rest from pre-dosing (baseline) to post-dosing (Week 16).
- Change from baseline to Week 24 in 6-minute walk distance (6MWD) [ Time Frame: From baseline to Week 24 ]The purpose of the 6-minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. This endpoint evaluates the change in 6MWD from pre-dosing (baseline) to post-dosing (Week 24).
- Change from baseline to Week 24 in Borg dyspnea index [ Time Frame: From baseline to Week 24 ]The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement. This endpoint evaluates the change in the Borg dyspnea index assessed at the end of measuring the 6MWD from pre-dosing (baseline) to post-dosing (Week 24).
- Change from baseline to Week 24 in WHO functional class (WHO FC) [ Time Frame: From baseline to Week 24 ]This endpoint evaluates the change of WHO functional class from pre-dosing (baseline) to post-dosing (Week 24). Class I: no symptoms with exercise or at rest. No limitation of activity. Class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). Class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: symptoms at rest (e.g. dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms. Patients in class IV manifest signs of right heart failure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809650
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|Nagasaki University Hospital||Recruiting|
|Nagasaki, Japan, 852-8501|
|Contact: Principal Investigator +81 95 819 7200 email@example.com|
|Study Director:||Yoshinari Yokoyama, PhD||Actelion Japan|